1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed Show 7 more changesShow less
    • Final enrollment: 56 participants (planned 100)
    • Primary completion date changed from estimate of Sep 2026 to May 18, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 2 of 2 entries
  2. Minor Primary completion date: Apr 2026 to Sep 2026v12
  3. Notable Primary completion date: Apr 2025 to Apr 2026
    • Study completion date: Dec 2025 to Dec 2026
    • Study description expanded, about 5 words
    v11
  4. Notable Primary completion date: Apr 2024 to Apr 2025
    • Study completion date: May 2025 to Dec 2025
    • Eligibility criteria expanded, about 3 words
    • Study description expanded, about 3 words
    v10
  5. Minor Start date changed from estimate of Jun 2023 to Jun 26, 2023
    • Eligibility criteria expanded, about 45 words
    • Study description expanded, about 18 words
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Start date: May 2023 to Jun 2023v8
  2. Minor Start date: Apr 2023 to May 2023v7
  3. Notable Start date: Feb 2023 to Apr 2023v6
  4. Minor Eligibility criteria shortened, about 3 wordsv5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  6. Minor Eligibility criteria shortened, about 2 wordsv3
  7. Minor Secondary endpoints revised (5)
    • Study description shortened, about 3 words
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train Black women living with HIV (BWLWHI) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access internal and external sources of strength (e.g. self-reliance, safety net); safety strategies, knowledge about Undetectable = Untransmissible (U=U) and HIV care; and reduce internalized and anticipated stigma; 2) communication skills to respond to enacted HIV and IPV stigma and enlist social support; and 3) addressing structural barriers to HIV care engagement with an HIV navigator component. The intervention is informed by the HIV-Stigma Framework and a resilient-reintegration model which views women as active participants in responding to IPV and managing life with HIV. Aim 1: Examine preliminary efficacy of the 1MoreStep intervention on: (a) IPV safety strategies (informal and formal resources, safety planning, and placating strategies at baseline, 3-month and 6-month follow-up visits); and (b) HIV care engagement (medical record confirmed visit with an HIV care provider, antiretroviral therapy (ART) prescription, medication adherence, and viral load status during 3-month and 6-month follow-up visits). Aim 2: Examine the acceptability and feasibility of the 1MoreStep intervention operationalized by (a) quantitative measures: session attendance and fidelity to key intervention components and (b) qualitative interviews to assess: program fit, facilitators and barriers to participation, and using 1MoreStep intervention skills.
Trial Details
NCT Number NCT05608421
Lead Sponsor Johns Hopkins University
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Violence, Domestic, HIV, Stigma, Social, Engagement, Patient, Medication Adherence
Related terms Medication Adherence, Patient Participation, Social Stigma
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov